Endoscope reprocessing system and method

ABSTRACT

A method for reprocessing a balloon endoscope, the method including the steps of deflating a balloon of a balloon endoscope to a negative pressure state following clinical use thereof and thereafter maintaining the interior of the balloon in a negative pressure state during at least part of reprocessing the balloon endoscope.

REFERENCE TO RELATED APPLICATIONS

Reference is made to U.S. Provisional Patent Application Ser. No.61/855,688, filed May 21, 2013 and entitled “ENDOSCOPE REPROCESSINGASSEMBLY AND METHODS” and to U.S. Provisional Patent Application Ser.No. 61/962,383, filed Nov. 6, 2013 and entitled “ENDOSCOPIC REPROCESSINGSYSTEM UTILIZING NEGATIVE AIR PRESSURE”, the disclosures of which arehereby incorporated by reference and priority of which is hereby claimedpursuant to 37 CFR 1.78(a) (4) and (5)(i).

Reference is also made to the following applicant's Published PCT PatentApplications which are believed to be related to the presentapplication, the contents of which are hereby incorporated by referenceherein:

WO2005/074377; WO2007/017854; WO2007/135665; WO2008/004228;WO2008/142685; WO2009/122395; WO2010/046891; WO02010/137025;WO2011/111040; and WO2014/068569.

FIELD OF THE INVENTION

The present invention relates to endoscope reprocessing systems andmethods.

BACKGROUND OF THE INVENTION

Various endoscope reprocessing systems and methods are known.

SUMMARY OF THE INVENTION

The present invention seeks to provide improved endoscope reprocessingmethods and systems.

There is thus provided in accordance with a preferred embodiment of thepresent invention a method for reprocessing a balloon endoscope, themethod including the steps of deflating a balloon of a balloon endoscopeto a negative pressure state following clinical use thereof andthereafter maintaining the interior of the balloon in a negativepressure state during at least part of reprocessing said balloonendoscope.

Preferably, the reprocessing includes cleaning and the maintaining theinterior of the balloon in a negative pressure state during at leastpart of reprocessing the balloon endoscope includes maintaining theinterior of the balloon in a negative pressure state during at leastpart of the cleaning. Additionally, the cleaning includes at leastautomated cleaning and the maintaining the interior of the balloon in anegative pressure state during at least part of reprocessing the balloonendoscope includes maintaining the interior of the balloon in a negativepressure state during at least part of the automated cleaning.

In accordance with a preferred embodiment of the present invention thereprocessing includes disinfecting and the maintaining the interior ofthe balloon in a negative pressure state during at least part ofreprocessing the balloon endoscope includes maintaining the interior ofthe balloon in a negative pressure state during at least part of thedisinfecting. Preferably, the cleaning includes at least automateddisinfecting and the maintaining the interior of the balloon in anegative pressure state during at least part of reprocessing the balloonendoscope includes maintaining the interior of the balloon in a negativepressure state during at least part of the automated disinfecting.

Preferably, fluid communication exists between the interior of theballoon and an interior volume of the balloon endoscope and themaintaining the interior of the balloon in a negative pressure stateduring at least part of reprocessing the balloon endoscope includesmaintaining the interior volume of the balloon endoscope in a negativepressure state during the at least part of reprocessing.

In accordance with a preferred embodiment of the present invention anormally-closed leak testing port is provided in fluid communicationwith the balloon endoscope and the maintaining the interior volume ofthe balloon endoscope in a negative pressure state during the at leastpart of reprocessing includes deflating the interior volume of theballoon endoscope through the leak testing port. Additionally, thedeflating the interior volume of the balloon endoscope through the leaktesting port includes coupling a negative pressure device to the leaktesting port and operating the negative pressure device to apply vacuumto the interior volume of the endoscope, thereafter, disconnecting thenormally-closed leak testing port from the negative pressure pump andmaintaining, by the normally-closed leak testing port, negative pressurein the interior volume of the balloon endoscope.

In accordance with a preferred embodiment of the present invention, thedeflating a balloon of a balloon endoscope to a negative pressure stateincludes deflating the balloon to a negative pressure sufficient tomaintain deflation of the balloon notwithstanding an increase intemperature encountered during the reprocessing. Preferably, thedeflating a balloon of a balloon endoscope to a negative pressure stateincludes deflating the balloon to a negative pressure in the range of −5mbar to −300 mbar. More preferably, the deflating a balloon of a balloonendoscope to a negative pressure state includes deflating the balloon toa negative pressure in the range of −100 mbar to −250 mbar. Inaccordance with a preferred embodiment of the present invention thedeflating a balloon of a balloon endoscope to a negative pressure stateincludes deflating the balloon to a negative pressure below −150 mbar.

Preferably, the deflating a balloon of a balloon endoscope to a negativepressure state includes deflating the balloon to a negative pressurelower than a negative pressure threshold which negative pressurethreshold varies over time during reprocessing. Additionally oralternatively, the deflating a balloon of a balloon endoscope to anegative pressure state includes deflating the balloon to a negativepressure lower than a negative pressure threshold which varies as afunction of the temperature at the balloon endoscope during thereprocessing. Alternatively or additionally, the deflating a balloon ofa balloon endoscope to a negative pressure state includes deflating theballoon to a negative pressure lower than a negative pressure thresholdwhich varies as a function of the measured negative pressure inside theballoon at a specific time prior to or during the reprocessing.

Preferably, the deflating a balloon of a balloon endoscope to a negativepressure state includes deflating the balloon to a negative pressurelower than a negative pressure threshold PT(t) where:

PT(t)=F(Tt,T0,P0),

where Tt is the temperature at the endoscope at a time t, T0 is thetemperature at the endoscope at an initial time t0 and P0 is thepressure at the interior of the balloon of the endoscope at the initialtime t0.

In accordance with a preferred embodiment of the present invention thedeflating a balloon of a balloon endoscope to a negative pressure stateincludes deflating the balloon to a negative pressure lower than anegative pressure threshold PT(t) where:

PT(t)=F1(Tt,T0,P0)+F2(t−t0)

where: Tt is the temperature at the endoscope at a time t, T0 is thetemperature at the endoscope at an initial time t0, P0 is the pressureat the interior of the balloon of the endoscope at the initial time t0and F2 is a function of the elapsed time from time t0 to t.

In accordance with a preferred embodiment of the present inventionF1=(Tt/T0)·P0, where Tt and T0 are measured in degrees Kelvin and P0 ismeasured in the absolute pressure units above zero pressure used forPT(t). Additionally or alternatively, F2=K·(t−t0), where K is aconstant, expressing change in pressure over time. Preferably, K is inthe range of 0.01-0.20 mbar per second. More preferably, K is in therange of 0.02-0.10 mbar per second.

In accordance with a preferred embodiment of the present invention themethod for reprocessing a balloon endoscope also includes the followingsteps, prior to deflating the balloon to the negative pressure state,inflating the balloon to a positive pressure state following clinicaluse thereof and cleaning the balloon when it is in the positive pressurestate.

There is also provided in accordance with another preferred embodimentof the present invention a balloon endoscope reprocessing systemincluding a balloon endoscope including a balloon having an interiorvolume and a valve communicating with the interior volume of theballoon, balloon deflation control functionality communicating with theinterior volume of the balloon via the valve and being operative tocause the interior volume to be in a negative pressure state and balloonendoscope reprocessing functionality for receiving and at least one ofcleaning and disinfecting the balloon endoscope when the interior volumeof the balloon is maintained in a negative pressure state.

Preferably, the balloon endoscope reprocessing functionality includesautomated endoscope reprocessing functionality.

In accordance with a preferred embodiment of the present invention fluidcommunication exists between the interior of the balloon and an interiorvolume of the balloon endoscope and the interior volume of the balloonendoscope is maintained in a negative pressure state during the at leastpart of reprocessing by the balloon endoscope reprocessingfunctionality. Additionally, the valve includes a normally-closed leaktesting port in fluid communication with the interior volume of theballoon endoscope and the balloon deflation control functionalitymaintains the interior volume of the balloon endoscope in the negativepressure state during the at least part of reprocessing by deflating theinterior volume of the balloon endoscope through the leak testing port.

In accordance with a preferred embodiment of the present invention, theballoon deflation control functionality is operative for deflating theballoon to a negative pressure sufficient to maintain deflation of theballoon notwithstanding an increase in temperature encountered duringthe reprocessing. Preferably, the balloon deflation controlfunctionality is operative for deflating the balloon to a negativepressure in the range of −5 mbar to −300 mbar. More preferably, theballoon deflation control functionality is operative for deflating theballoon to a negative pressure in the range of −100 mbar to −250 mbar.In accordance with a preferred embodiment of the present invention theballoon deflation control functionality is operative for deflating theballoon to a negative pressure below −150 mbar.

Preferably, the balloon deflation control functionality is operative fordeflating the balloon to a negative pressure lower than a negativepressure threshold, which negative pressure threshold varies over timeduring reprocessing. Additionally or alternatively, the balloondeflation control functionality is operative for deflating the balloonto a negative pressure lower than a negative pressure threshold whichvaries as a function of the temperature at the balloon endoscope duringthe reprocessing. Alternatively or additionally, the balloon deflationcontrol functionality is operative for deflating the balloon to anegative pressure lower than a negative pressure threshold which variesas a function of the measured negative pressure inside the balloon at aspecific time prior to or during the reprocessing.

In accordance with a preferred embodiment of the present invention theballoon deflation control functionality is operative for deflating theballoon to a negative pressure lower than a negative pressure thresholdPT(t) where:

PT(t)=F(Tt,T0,P0),

where Tt is the temperature at the endoscope at a time t, T0 is thetemperature at the endoscope at an initial time t0 and P0 is thepressure at the interior of the balloon of the endoscope at the initialtime t0.

In accordance with a preferred embodiment of the present invention theballoon deflation control functionality is operative for deflating theballoon to a negative pressure lower than a negative pressure thresholdPT(t) where:

PT(t)=F1(Tt,T0,P0)+F2(t−t0)

where Tt is the temperature at the endoscope at a time t, T0 is thetemperature at the endoscope at an initial time t0, P0 is the pressureat the interior of the balloon of the endoscope at the initial time t0and F2 is a function of the elapsed time from time t0 to t.

Preferably, F1=(Tt/T0)·P0, where Tt and T0 are measured in degreesKelvin and P0 is measured in the absolute pressure units above zeropressure used for PT(t). Additionally or alternatively, F2=K·(t−t0),where K is a constant, expressing change in pressure over time.Preferably, K is in the range of 0.01-0.20 mbar per second. Morepreferably, K is in the range of 0.02-0.10 mbar per second.

There is further provided in accordance with yet another preferredembodiment of the present invention a balloon endoscope reprocessingsystem including automated balloon endoscope reprocessing functionalityfor receiving and at least one of cleaning and disinfecting a balloonendoscope and balloon deflation control functionality which is operativeto maintain the interior volume of the balloon in a negative pressurestate during at least part of operation of the automated balloonendoscope reprocessing functionality.

Preferably, the balloon deflation control functionality is operative tomaintain the interior of the balloon in a negative pressure state duringall of the operation of the automated balloon endoscope reprocessingfunctionality.

In accordance with a preferred embodiment of the present invention fluidcommunication exists between the interior of the balloon and an interiorvolume of the balloon endoscope and the interior volume of the balloonendoscope is maintained in a negative pressure state during the at leastpart of reprocessing by the balloon endoscope reprocessingfunctionality. Additionally, the valve includes a normally-closed leaktesting port in fluid communication with the interior volume of theballoon endoscope and the balloon deflation control functionalitymaintains the interior volume of the balloon endoscope in the negativepressure state during the at least part of reprocessing by deflating theinterior volume of the balloon endoscope through the leak testing port.

In accordance with a preferred embodiment of the present invention theballoon deflation control functionality is operative for deflating theballoon to a negative pressure sufficient to maintain deflation of theballoon notwithstanding an increase in temperature encountered duringthe reprocessing. Preferably, the balloon deflation controlfunctionality is operative for deflating the balloon to a negativepressure in the range of −5 mbar to −300 mbar. More preferably, theballoon deflation control functionality is operative for deflating theballoon to a negative pressure in the range of −100 mbar to −250 mbar.In accordance with a preferred embodiment of the present invention theballoon deflation control functionality is operative for deflating theballoon to a negative pressure below −150 mbar.

In accordance with a preferred embodiment of the present invention theballoon deflation control functionality is operative for deflating theballoon to a negative pressure lower than a negative pressure threshold,which negative pressure threshold varies over time during reprocessing.Additionally or alternatively, the balloon deflation controlfunctionality is operative for deflating the balloon to a negativepressure lower than a negative pressure threshold which varies as afunction of the temperature at the balloon endoscope during thereprocessing. Alternatively or additionally, the balloon deflationcontrol functionality is operative for deflating the balloon to anegative pressure lower than a negative pressure threshold which variesas a function of the measured negative pressure inside the balloon at aspecific time prior to or during the reprocessing.

In accordance with a preferred embodiment of the present invention theballoon deflation control functionality is operative for deflating theballoon to a negative pressure lower than a negative pressure thresholdPT(t) where:

PT(t)=F(Tt,T0,P0),

where Tt is the temperature at the endoscope at a time t, T0 is thetemperature at the endoscope at an initial time t0 and P0 is thepressure at the interior of the balloon of the endoscope at the initialtime t0.

In accordance with a preferred embodiment of the present invention theballoon deflation control functionality is operative for deflating theballoon to a negative pressure lower than a negative pressure thresholdPT(t) where:

PT(t)=F1(Tt,T0,P0)+F2(t−t0)

where Tt is the temperature at the endoscope at a time t,T0 is thetemperature at the endoscope at an initial time t0, P0 is the pressureat the interior of the balloon of the endoscope at the initial time t0and F2 is a function of the elapsed time from time t0 to t.

Preferably, F1=(Tt/T0)·P0, where Tt and T0 are measured in degreesKelvin and P0 is measured in the absolute pressure units above zeropressure used for PT(t). Additionally or alternatively, F2=K·(t−t0),where K is a constant, expressing change in pressure over time.Preferably, K is in the range of 0.01-0.20 mbar per second. Morepreferably, K is in the range of 0.02-0.10 mbar per second.

In accordance with a preferred embodiment of the present invention theballoon endoscope reprocessing system also includes negative pressureleak testing functionality operative to detect leaks in the balloonendoscope under negative pressure during reprocessing.

Preferably, the negative pressure leak testing functionality isconfigured to be coupled to a leak test port of an endoscope for sensingleaks in the endoscope under negative pressure and includes an indicatoroperative in response to operation of the negative pressure leak testfunctionality for indicating the presence or absence of a leak in theendoscope. Additionally or alternatively, the negative pressure leaktesting functionality is operative to sense leaks at multiple timesduring the reprocessing. In accordance with a preferred embodiment ofthe present invention the multiple times occur periodically.Alternatively, the multiple times occur immediately one after the other.

In accordance with a preferred embodiment of the present invention theballoon endoscope reprocessing system also includes non-balloonendoscope reprocessing functionality.

Preferably, the balloon endoscope reprocessing system also includes anoperator selection interface allowing an operator to selectfunctionality suitable for reprocessing of a balloon endoscope orfunctionality suitable for reprocessing of a non-balloon endoscope.

In accordance with a preferred embodiment of the present invention thenegative pressure leak test functionality is operative to perform leaktesting when the interior volume of the endoscope is at a negativepressure which is different from a negative pressure of the interiorvolume of the endoscope during reprocessing when leak testing is nottaking place. Additionally, the negative pressure of the interior volumeof the endoscope during the leak testing is at a stronger vacuum thanthe negative pressure of the interior volume of the endoscope duringreprocessing when leak testing is not taking place.

There is even further provided in accordance with still anotherpreferred embodiment of the present invention a leak testing device foruse with an endoscope having a leak test port, the leak testing deviceincluding negative pressure leak test functionality configured to becoupled to a leak test port of an endoscope for sensing leaks in theendoscope under negative pressure and an indicator operative in responseto operation of the negative pressure leak test functionality forindicating the presence or absence of a leak in the endoscope.

Preferably, the negative pressure leak test functionality is operativefor performing the leak testing when the negative pressure is in therange of −5 mbar to −300 mbar. More preferably, the negative pressureleak test functionality is operative for performing the leak testingwhen the negative pressure is in the range of −100 mbar to −250 mbar. Inaccordance with a preferred embodiment of the present invention thenegative pressure leak test functionality is operative for performingthe leak testing when the negative pressure is below −150 mbar.

In accordance with a preferred embodiment of the present invention theleak testing device for use with an endoscope is suitable for use inconjunction with reprocessing of a balloon endoscope having an interiorvolume and the device also includes negative pressure establishmentfunctionality operative subsequent to at least one leak test toestablish a negative pressure in the interior volume of the balloonendoscope which is suitable for reprocessing of the balloon endoscope.

Preferably, the leak testing device for use with an endoscope alsoincludes positive pressure leak testing functionality. Additionally, thepositive pressure leak testing functionality includes functionality foreliminating false leak indications resulting from expansion of anendoscope balloon over time during leak testing.

In accordance with a preferred embodiment of the present invention theleak testing device for use with an endoscope also includes automaticballoon endoscope/non-balloon endoscope sensing functionality.Additionally, the leak testing device for use with an endoscope alsoincludes a computerized controller for operating the leak testing devicedifferently depending on whether it is connected to a balloon endoscopeor a non-balloon endoscope.

There is still further provided in accordance with another preferredembodiment of the present invention a leak testing method for use withan endoscope having a leak test port, the method including couplingnegative pressure leak test functionality to an interior volume of anendoscope, employing the negative pressure leak test functionality forsensing leaks in the endoscope under negative pressure and in responseto operation of the negative pressure leak test functionality,indicating the presence or absence of a leak in the endoscope.

Preferably, the negative pressure leak test functionality is operativefor performing the leak testing when the negative pressure is in therange of −5 mbar to −300 mbar. More preferably, the negative pressureleak test functionality is operative for performing the leak testingwhen the negative pressure is in the range of −100 mbar to −250 mbar. Inaccordance with a preferred embodiment of the present invention thenegative pressure leak test functionality is operative for performingthe leak testing when the negative pressure is below −150 mbar.

In accordance with a preferred embodiment of the present invention theleak testing method, for use with an endoscope which is suitable for usein conjunction with reprocessing of a balloon endoscope having aninterior volume, also includes, subsequent to performing at least oneleak test, establishing a negative pressure in the interior volume ofthe balloon endoscope which negative pressure is suitable forreprocessing of the balloon endoscope.

Preferably, the leak testing method for use with an endoscope alsoincludes positive pressure leak testing. Additionally, the positivepressure leak testing includes eliminating false leak indicationsresulting from expansion of an endoscope balloon over time during leaktesting.

In accordance with a preferred embodiment of the present invention theleak testing method for use with an endoscope also includes automaticsensing of a connection to either a balloon endoscope or a non-balloonendoscope. Additionally, the leak testing method for use with anendoscope also includes operating the leak testing device differentlydepending on whether it is connected to a balloon endoscope or anon-balloon endoscope.

There is also provided in accordance with yet another preferredembodiment of the present invention an endoscope reprocessing systemhaving dual mode leak test port connection functionality which has afirst, non-balloon endoscope, reprocessing mode in which pressurized gasis supplied to a leak test port of a non-balloon endoscope undergoingreprocessing and a second, balloon endoscope, reprocessing mode in whichpressurized gas is not supplied to a leak test port of a balloonendoscope.

There is even further provided in accordance with still anotherpreferred embodiment of the present invention a retrofit automatedballoon endoscope reprocessing system for use with a conventionalautomated reprocessing machine, having a source of pressurized gas,which conventional automated reprocessing machine is not suitable forreprocessing balloon endoscopes, the retrofit system including apre-reprocessing balloon endoscope balloon deflation verifier and aballoon endoscope reprocessing enabler, allowing normal operation of theconventional automated reprocessing machine while the leak test port ofthe balloon endoscope is not in pressurized gas communication with asource of pressurized gas.

There is yet further provided in accordance with even yet anotherpreferred embodiment of the present invention a retrofit automatedballoon endoscope reprocessing system for use with a conventionalautomated reprocessing machine, having a source of pressurized gas,which conventional automated reprocessing machine is not suitable forreprocessing balloon endoscopes, the retrofit system including apre-reprocessing balloon endoscope balloon deflation verifier and areprocessing balloon endoscope leak test port inflation preventeroperative to prevent inflation of a balloon of a balloon endoscope viaits leak test port while allowing otherwise normal operation of theconventional automated reprocessing machine.

There is still further provided in accordance with another preferredembodiment of the present invention an endoscope leak test deviceincluding a leak test port coupler, a computerized negative pressureapplier configured to apply negative pressure to a leak test port of anendoscope via the leak test port coupler and a computerized pressuresensor configured to sense changes in pressure over time at the leaktest port of the endoscope at a time when the leak test port is undernegative pressure.

There is also provided in accordance with yet another preferredembodiment of the present invention an endoscope leak test deviceincluding a leak test port coupler, a computerized pressure applierconfigured to apply, at different times, positive pressure and negativepressure to a leak test port of an endoscope via the leak test portcoupler and a computerized pressure sensor configured to sense changesin pressure over time at the leak test port of the endoscope both at atime when the leak test port is under positive pressure and at a timewhen the leak test port is under negative pressure.

There is further provided in accordance with still another preferredembodiment of the present invention an endoscope leak test deviceincluding a positive pressure source, a negative pressure source, acomputerized pressure controller configured to apply, at differenttimes, positive pressure from the positive pressure source and negativepressure from the negative pressure source to a leak test port of anendoscope and a computerized pressure sensor configured to sense changesin pressure over time at the leak test port of the endoscope both at atime when the leak test port is under positive pressure and at a timewhen the leak test port is under negative pressure.

There is still further provided in accordance with yet another preferredembodiment of the present invention an automated endoscope reprocessorincluding an endoscope reprocessing chamber which is configured forreceiving an endoscope to be reprocessed, a fluid supply subsystemoperative to provide a flow of reprocessing materials to the endoscopereprocessing chamber and a leak testing subsystem which is configuredfor connection to a leak test port of the endoscope to be reprocessed,the leak testing subsystem having negative pressure leak testingfunctionality for providing negative pressure leak testing of theendoscope.

Preferably, the automated endoscope reprocessor also includes acomputerized controller coordinating the relative timing of operation ofthe fluid supply subsystem and the leak testing subsystem.

In accordance with a preferred embodiment of the present invention thefluid supply subsystem provides fluid at an elevated temperature to theendoscope reprocessing chamber during at least one phase of operation ofthe reprocessor and the computerized controller ensures that an interiorvolume of the endoscope is at least at a predetermined negative pressureduring the at least one phase of operation of the reprocessor.Additionally, the computerized controller is operative to selectablygovern the operation of the fluid supply system and the leak testingsubsystem in a balloon endoscope reprocessing mode and in a non-balloonendoscope processing mode. Preferably, the computerized controller isoperative in the balloon endoscope reprocessing mode to perform leaktesting only while the balloon endoscope is in a depressurized statesuch that a balloon thereof is in a deflated state. Additionally oralternatively, the computerized controller is operative in the balloonendoscope reprocessing mode to perform reprocessing only while theballoon endoscope is in a depressurized state such that a balloonthereof is in a deflated state.

There is yet further provided in accordance with still another preferredembodiment of the present invention a method for reprocessing a balloonendoscope, having an endoscope interior volume, and including a balloon,having a balloon interior volume, the endoscope interior volume and theballoon interior volume being normally in fluid communication via atleast one aperture, the method including sealing the at least oneaperture during at least part of reprocessing of the balloon endoscope.

Preferably, the sealing is effected by mechanically sealing the at leastone aperture. Additionally, the sealing is effected by application ofvacuum to the endoscope interior volume which tightly holds the balloonin sealing engagement with the at least one aperture. Preferably, theballoon is mounted over an outer sheath of the balloon endoscope and thesealing is effected by application of an external clip which isoperative to press the balloon against the outer sheath,circumferentially around the at least one aperture, thereby sealing theat least one aperture. More preferably, the sealing is effected byapplication of a mechanical sealing element which is operative to blockthe at least one aperture, thereby sealing the at least one aperture andpreventing flow of fluids therethrough. Yet preferably, the mechanicalsealing element is placed interiorly of the balloon.

There is yet further provided in accordance with still another preferredembodiment of the present invention a balloon endoscope having anendoscope interior volume and including a balloon which is sealinglymounted over an outer sheath of the balloon endoscope and having aballoon interior volume, at least one aperture disposed in the outersheath underneath the balloon and normally providing fluid communicationbetween the endoscope interior volume and the balloon interior volume,and a sealing element operative for sealing the at least one apertureduring at least part of reprocessing of the balloon endoscope.Preferably, the sealing element includes an external clip which isoperative to press the balloon against the outer sheath,circumferentially around the at least one aperture, thereby sealing theat least one aperture. Alternatively, the sealing element includes amechanical sealing element which is operative to block the at least oneaperture, thereby sealing the at least one aperture and preventing flowof fluids therethrough. Preferably, the mechanical sealing element isplaced interiorly of said balloon.

There is even further provided in accordance another preferredembodiment of the present invention a method for preparing a balloonendoscope for reuse, the method including the steps of inflating aballoon of a balloon endoscope to a positive pressure state followingclinical use thereof, cleaning the balloon when it is in the positivepressure state, thereafter deflating the balloon of a balloon endoscopeto a negative pressure state and thereafter reprocessing the balloonendoscope while maintaining the interior of the balloon in a negativepressure state during at least part of reprocessing the balloonendoscope.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be understood and appreciated more fully fromthe following detailed description, taken in conjunction with thedrawings in which:

FIGS. 1A, 1B, 1C and 1D are simplified illustrations of a reprocessingmethod operative in accordance with a preferred embodiment of thepresent invention;

FIG. 2 is a simplified illustration of details of one of the steps shownin FIG. 1B;

FIG. 3 is a simplified block diagram illustration of a leak testeruseful in an embodiment of the reprocessing method of FIGS. 1A & 1B;

FIGS. 4A, 4B and 4C are together a simplified flow chart of theoperation of the leak tester of FIG. 3 in accordance with one embodimentof the present invention;

FIGS. 5A and 5B are together a simplified flow chart of the operation ofthe leak tester of FIG. 3 in accordance with another embodiment of thepresent invention;

FIG. 6 is a simplified system block diagram illustration of an automatedreprocessing system constructed and operative in accordance with apreferred embodiment of the present invention;

FIGS. 7A and 7B are together a simplified flow chart of the operation ofthe reprocessing system of FIG. 6 in accordance with one embodiment ofthe present invention;

FIGS. 8A, 8B and 8C are together a simplified flow chart of theoperation of the reprocessing system of FIG. 6 in accordance withanother embodiment of the present invention; and

FIGS. 9A and 9B are simplified illustrations of a reprocessing methodoperative in accordance with a preferred embodiment of the presentinvention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Unless specifically indicated herein to the contrary, negative pressure,or vacuum, is defined hereinbelow as a pressure lower than ambient,typically atmospheric, pressure. Accordingly, a decrease in vacuum meansan increase in the absolute pressure, which remains lower than ambientpressure. More specifically, a higher negative pressure means a weakervacuum, and a negative pressure lower than a given pressure thresholdmeans a pressure which is lower in its absolute value (above zeropressure) than that given pressure threshold.

Reference is now made to FIGS. 1A-1D, which are simplified illustrationsof a reprocessing method operative in accordance with a preferredembodiment of the present invention and to FIG. 2, which is a simplifiedillustration of details of one of the steps shown in FIG. 1D.

As seen in FIGS. 1A-2, there is provided a reprocessing method for aballoon endoscope, which is particularly characterized in that itincludes: deflating a balloon of a balloon endoscope to a negativepressure state following clinical use thereof; and thereaftermaintaining the interior of the balloon in a negative pressure stateduring at least part of reprocessing said balloon endoscope.

There is also provided a method for reprocessing a balloon endoscopehaving a balloon interior volume and an endoscope interior volume whichare normally in fluid communication via at least one aperture, themethod comprising sealing the at least one aperture during at least partof reprocessing of the balloon endoscope.

FIG. 1A, illustrates steps carried out in an endoscopy room. Step A,shown in FIG. 1A, illustrates a balloon endoscope 100, such as a modelG-EYE™ 3890i colonoscope, commercially available from Smart MedicalSystems of 10 Hayetsira street, Raanana 43663, Israel, after having beenremoved from the body of a patient following an endoscopic procedure,such as a colonoscopy. At this stage, the balloon of the balloonendoscope 100 may be inflated or deflated.

During the endoscopic procedure and immediately thereafter at Steps Aand B, the balloon endoscope 100 is operatively connected with aninflation/deflation system 102, such as a SPARK2C inflation system,commercially available from Smart Medical Systems of Raanana, Israel.Specifically a flexible inflation/deflation tube 104 is sealinglyconnected at one end thereof to a normally-closed leak-test port 106 ofballoon endoscope 100, as seen in enlargement A, and is sealinglyconnected at an opposite end thereof to an inflation/deflation tubeconnection port 108 of the inflation/deflation system 102.

As further seen in FIG. 1A, balloon endoscope 100 includes a balloon 110at its forward portion, which is sealingly mounted over an outer sheath112 of balloon endoscope 100. An interior volume 113 of balloon 110 isnormally in fluid communication with an interior volume 114 of balloonendoscope 100, via at least one aperture 116 formed in the outer sheath112 of the endoscope 100. It is thus appreciated that balloon 110 may beinflated and deflated by inflation/deflation system 102 via flexibleinflation/deflation tube 104, leak test port 106, interior volume 114 ofballoon endoscope 100, and at least one aperture 116, altogether forminga continuous fluid communication path between inflation/deflation system102 and the interior volume 113 of balloon 110.

It is appreciated that the volume of balloon endoscope 100 interiorly ofouter sheath 112 may contain various conduits and channels passingtherethrough (not shown), such as optical and illumination bundles,electronics, steering wires, instrument channel, and other components asappropriate. It is appreciated that inflation/deflation air can flowfreely through the interior volume 114, which is the volume interior toouter sheath 112 that is not occupied by such conduits and channels.

In step B, shown in FIG. 1A, it is seen that if the balloon 110 of theendoscope 100 is not already fully deflated, as seen in enlargement B,the operator presses on a deflate control button 117 of aninflation/deflation control unit 118 of the inflation/deflation system102 to cause the inflation/deflation system 102 to fully deflate theballoon 110.

It is a particular feature of an embodiment of the present inventionthat deflation of the balloon 110 effects sealing, as shown inenlargement C, during at least part of reprocessing of the balloonendoscope, of the at least one aperture 116 formed in the outer sheath112 of the endoscope 100, which aperture normally provides fluidcommunication between the interior volume 113 of balloon 110 and theinterior volume 114 of the endoscope 100. This is important in order toensure that any reprocessing fluids that might somehow enter theinterior volume 113 of balloon 110 from the outside during reprocessingdo not enter the interior volume 114 of the endoscope.

It is appreciated that such sealing, during at least part ofreprocessing of the balloon endoscope, of the at least one aperture 116,could be provided otherwise than by means of deflation of the balloon110, such as by a mechanical sealing element or shutter that blocks theat least one aperture 116 and prevents flow of fluids therethrough. Itis further appreciated that such a mechanical sealing element or shuttermay be placed either exteriorly or interiorly of outer sheath 112 and/orballoon 110.

FIG. 1B shows mechanical sealing of aperture 116 by an external clip120, which is operative to press balloon 110 against the outer sheath112, circumferentially around the at least one aperture 116, therebysealing the at least one aperture 116 and blocking flow of fluidstherethrough. Step A in FIG. 1B shows the external clip 120 prior tooperative engagement with balloon 110 and outer sheath 112, and step Bin FIG. 1B shows the clip 120 in pressing operative engagement withballoon 110 and outer sheath 112 around the aperture 116, therebysealing it.

FIG. 1C shows mechanical sealing of the at least one aperture 116 by amechanical shutter 122, forming part of endoscope 100 and located inproximity to the at least one aperture 116 and interiorly of balloon110. In the example of FIG. 1C, mechanical shutter 122 is formed of acircular band encircling outer sheath 112 around and over the at leastone aperture 116, having an oval shutter aperture 124 formed therein.Preferably, the dimensions of shutter aperture 124 are larger than thatof the at least one aperture 116.

At step A shown in FIG. 1C, mechanical shutter 122 assumes a non-sealingorientation, wherein shutter aperture 124 is positioned over aperture116, thereby allowing flow of fluids through aperture 116, as applicablein the clinical use of endoscope 100. Step B in FIG. 1C shows themechanical shutter 122 being rotated counter-clockwise, such as by anoperator manually rotating it through the flexible balloon 110, so as toradially mis-align shutter aperture 124 with respect to aperture 116,and seal aperture 116 by shutter 122.

Returning now to FIG. 1A, at step C the operator disconnects theflexible inflation/deflation tube 104 from normally-closed leak-testport 106 of balloon endoscope 100. Due to the normally-closed operationof leak-test port 106, interior volume 114 of endoscope 100 remains in avacuum state and the balloon 110 remains fully deflated.

Step D of FIG. 1A, shows subsequent shut-down of the inflation/deflationsystem 102.

It is a particular feature of the embodiment of the present inventiondescribed with reference to FIG. 1A that balloon endoscope 100, whileballoon 110 is in a deflated state, is disconnected frominflation/deflation system 102 while the inflation/deflation system 102is powered on and thereby maintaining vacuum in interior volume 114 ofendoscope 100 and deflation of balloon 110, and that system 102 ispowered off only after its disconnection from endoscope 100.

FIG. 1D shows subsequent steps which take place in a reprocessing roomof a medical facility, which is separate from and typically adjacent tothe endoscopy room. Step A shown in FIG. 1D, shows balloon endoscope 100being brought into the reprocessing room, it being noted that at thisstage the balloon 110 is in a fully deflated state, as seen inenlargement A.

Step B, shown in FIG. 1D, shows an optional leak testing procedure whichis carried out preferably using a leak tester 126 of the type describedhereinbelow with reference to FIGS. 3-5B.

Step C, shown in FIG. 1D, shows an optional manual reprocessingprocedure wherein the balloon endoscope 100 is cleaned and disinfectedby hand, preferably according to the procedure set forth in theInstructions For Use (IFU) document provided with balloon endoscopemodel G-EYE™ 3890i colonoscope, commercially available from SmartMedical Systems of Raanana, Israel, it being noted that reprocessingtakes place while balloon 110 is in a fully deflated state, as seen inenlargement A.

Step D, shown in FIG. 1D, shows an alternative or additional automatedreprocessing procedure, typically employing an automated reprocessingmachine 128 such as a Model WASSENBURG® WD440 Endoscope WasherDisinfector, commercially available from Wassenburg Medical Devices B.V.of Edisonring 9, 6669 NA, Dodewaard, the Netherlands. It is appreciatedthat if Step C is employed, step D may be obviated and vice versa,although both steps may also be employed. It is noted that reprocessingtakes place while balloon 110 is in a fully deflated state, as seen inenlargement A.

Step E, shown in FIG. 1D, shows storage of reprocessed balloonendoscopes 100, it being noted that they are preferably stored withtheir balloons 110 in a fully deflated state, as seen in enlargement A.

Reference is now made to FIG. 2, which is a simplified illustration ofdetails of one of the steps shown in FIG. 1D. As seen in FIG. 2, anautomated reprocessing machine 128, such as Model WASSENBURG® WD440Endoscope Washer Disinfector, commercially available from WassenburgMedical Devices B.V. of Edisonring 9, 6669 NA, Dodewaard, theNetherlands, is employed. Automated reprocessing machine 128 typicallyincludes a tube 150, which is, in the prior art, connected to a leaktest port of a non-balloon endoscope via a leak test port connector 155.During conventional reprocessing of a non-balloon endoscope by theconventional automated reprocessing machine 128, the interior volume ofthe non-balloon endoscope may be pressurized through tube 150, formonitoring and detecting potential leaks in the non-balloon endoscope.

In accordance with a preferred embodiment of the present invention,conventional automated reprocessing machines 128 can be employed forreprocessing of balloon endoscopes 100 while balloon 110 is deflated andthe interior volume of balloon-endoscope 100 is in vacuum state,preferably by attaching a sealing plug 160 to the leak test portconnector 155 at the corresponding end of tube 150, thereby sealing tube150.

It is appreciated that were tube 150 connected to the leak-test port ofendoscope 100, this would result in rupture of balloon 110 due toinflation of the balloon 110 during reprocessing. Were tube 150 leftunconnected, this would be perceived by automated reprocessing machine128 as a leak in the reprocessed endoscope, and would result in amalfunction indication, preventing operation of the automatedreprocessing machine 128.

Step A in FIG. 2 shows the balloon endoscope 100 being placed in areprocessing chamber 165 of the conventional reprocessing machine 128,and the sealing plug 160 being inserted to the leak test port connector155 of tube 150, thereby sealing tube 150 and providing a retrofittedreprocessing system which can reprocess balloon endoscope 100 in aconventional manner, while balloon 110 is deflated, as seen at step B inFIG. 2.

It is appreciated that in the embodiment of FIGS. 1A-2, leak tester 126functions as a pre-reprocessing balloon endoscope balloon deflationverifier, which ensures deflation of balloon 110 of balloon endoscope100 prior to reprocessing, and sealing plug 160 functions as a balloonendoscope reprocessing enabler, allowing normal operation of theconventional automated reprocessing machine 128 while the leak test port106 of balloon endoscope 100 is not in pressurized gas communicationwith a source of pressurized gas of conventional automated reprocessingmachine 128.

Reference is now made to FIG. 3, which is a simplified block diagramillustration of a leak tester 126 useful in an embodiment of thereprocessing method of FIGS. 1A-1D.

As seen in FIG. 3, the leak tester comprises a leak test port coupler200, which is adapted to connect with a leak test port of a conventionalnon-balloon endoscope or a conventional balloon endoscope.

A positive gas pressure source, such as an air pump 202 and a negativegas pressure source, such as a vacuum pump 204 are preferably connectedto leak test port coupler 200 via a manifold 206 and automaticallycontrollable valves 208 and 210 and a flexible tube 212. A computerizedcontroller 220 is operative to control the operation of pumps 202 and204 and/or valves 208 and 210 in order to apply at different times,positive pressure and negative pressure to the leak test port of anendoscope via the leak test port coupler 200. Alternatively, a singlepump providing at different times, positive and negative pressure may beemployed. An example of such a pump is a model 250 EC, commerciallyavailable from Schwarzer Precision GmbH+Co. KG of Am Lichtbogen 7, 45141Essen, Germany.

A computerized pressure sensor 230 is preferably coupled to leak testport coupler 200 and may also be coupled to pumps 202 and 204 via avalve 232 and is configured to sense changes in pressure over time atthe leak test port of the endoscope both at a time when the leak testport is under positive pressure and at a time when the leak test port isunder negative pressure.

Preferably, each of valves 208 and 210 is an automatically controllablevalve having two states—an “open” state in which the valve allows gasflow between the corresponding pump and the manifold 206, and a “closed”state in which the valve blocks gas flow between the pump and themanifold 206.

Preferably, valve 232 is an automatically controllable two-state valve,which can be positioned in either an “open” state in which it connectstube 212 and manifold 206 to the ambient via a purge tube 238, and a“closed” state in which it connects manifold 206 and tube 212 to eachother while disconnecting them from purge tube 238 and preventing aircommunication with the ambient.

In accordance with a preferred embodiment of the present invention, thecomputerized controller 220 cooperates with the computerized pressuresensor 230 to carry out a positive and negative pressure leak testprotocol, two preferred embodiments of which are set forth in FIGS.4A-4C and 5A-5B.

A user interface 240 is preferably provided integrally with the leaktester 126 and preferably includes first and second visible indicators242 and 244, which respectively indicate test PASS or FAIL.

It is appreciated that in accordance with another preferred embodimentof the invention, only a negative pressure leak test is performed and insuch a case, the positive pressure pump 202 and its associatedconnections may be obviated.

Reference is now made to FIGS. 4A-4C, which are together a simplifiedflow chart of the operation of the leak tester of FIG. 3 in accordancewith one embodiment of the present invention.

As seen in FIGS. 4A-4C, an initial step is to sealingly couple leak testport coupler 200 to the leak test port 106 of endoscope 100, such thatthe interior volume 114 of the endoscope 100 is in fluid communicationwith the leak tester 126.

Thereafter, all of valves 208, 210 and 232 (FIG. 3) are opened in orderto couple the interior volume of the endoscope to ambient pressure viathe leak tester 126. Once the interior volume 114 of the endoscope 100reaches ambient pressure, sensor 230 is calibrated accordingly.

Thereafter, valves 210 and 232 are closed and the positive pressure pump202 is operated by controller 220 to pressurize the interior volume ofendoscope 100 to a preferred pressure of typically 50 mbar, as sensed bysensor 230, thereby to inflate balloon 110 of endoscope 100. If,however, the preferred pressure of typically 50 mbar is not realizedwithin 10 seconds of onset of pressurization, a positive pressure testfailure indication is provided by controller 220, which actuates FAILindicator 244 accordingly.

If positive pressure test failure is not indicated at this stage, anoptional step can be performed by computerized controller 220, whichemploys readings from sensor 230 to sense and analyze the profile ofpressure change over time in the interior volume of the endoscope duringpressurization of the interior volume, and thereby determines whether aconventional non-balloon endoscope or a balloon endoscope is connectedto leak test port coupler 200.

For example, if a balloon endoscope is connected to the leak tester 126,it will take a longer time to pressurize the interior volume of theendoscope to a preset pressure compared to a non-balloon endoscope, dueto the additional volume of the balloon to be pressurized as well.Additionally, following pressurization of a balloon endoscope having anelastic balloon, the pressure will decrease over time due to balloonexpansion, while this pressure change profile will not take place in anon-balloon endoscope.

If this optional step is performed and it is thus ascertained that anon-balloon endoscope is being leak-tested, then a conventional leaktesting procedure will be performed, as in prior art positive pressureleak testers which employ positive pressure of typically 200 mbars. If,however, it is ascertained that a balloon endoscope is beingleak-tested, then a balloon endoscope leak testing procedure will beperformed, as described below.

In accordance with an embodiment of the present invention, mechanicalshutter 122 is employed, prior to leak testing of balloon endoscope 100,to seal aperture 116 as described hereinabove with reference to step Bin FIG. 1C. This will cause leak tester 126 to identify the balloonendoscope 100 as a non-balloon endoscope, and to perform conventionalpositive pressure leak testing of endoscope 100. It is appreciated thatalternatively, sealing of aperture 116 allows performance of leaktesting of balloon endoscope 100 by a conventional prior art leaktester, employing relatively high positive pressure of 200 mbar, withoutbursting or damaging balloon 110.

At this stage, the pressure in the interior volume of the endoscope 100is monitored again, after typically a further 25 seconds. If thepressure after 25 seconds has fallen to below a preferred threshold oftypically 30 mbar, a positive pressure test failure indication isprovided by controller 220, which actuates FAIL indicator 244accordingly. It is a particular feature of the present invention thatthe procedure described in this paragraph accommodates and takes intoaccount possible further expansion of the balloon 110, as a result ofits mechanical and elastic characteristics. Such further expansion ofballoon 110 over time during the leak testing procedure may result inreduction of the pressure monitored by sensor 230, and is not bemis-construed as a leak in balloon endoscope 100. Such a procedure isnot applicable to non-balloon endoscopes.

If positive pressure test failure is not indicated at this stage, thepressure in the interior volume 114 of the endoscope 100 is monitoredagain, after typically a further 20 seconds. If the pressure after thisfurther 20 seconds has fallen by more than 1 mbar, a positive pressuretest failure indication is provided by controller 220, which actuatesFAIL indicator 244 accordingly.

If positive pressure test failure is not indicated at this stage,negative pressure leak testing is initiated, typically by opening valve210, while maintaining valve 208 and valve 232 in a closed state, andoperating negative pressure pump 204 to depressurize the interior volumeof endoscope 100 to a preferred negative pressure of typically −200mbar, as sensed by sensor 230, and thereby to deflate balloon 110 ofendoscope 100. Optionally, if, the preferred pressure of typically −200mbar is not realized within 10 seconds of onset of depressurization, anegative pressure test failure indication is provided by controller 220,which actuates FAIL indicator 244 accordingly.

If negative pressure test failure is not indicated at this optionalstage, valve 232 is closed and then the negative pressure in theinterior volume of the endoscope 100 is monitored again, after typically20 seconds. If the negative pressure after 20 seconds has increased toabove a preferred threshold of typically −150 mbar, a negative pressuretest failure indication is provided by controller 220, which actuatesFAIL indicator 244 accordingly.

If negative pressure test failure is not indicated at this stage, thepressure in the interior volume of the endoscope 100 is monitored again,after typically a further 20 seconds. If the pressure after this further20 seconds has increased by more than 2 mbar, a negative pressure testfailure indication is provided by controller 220, which actuates FAILindicator 244 accordingly.

If negative pressure test failure is not indicated at this stage, apositive and negative pressure test success indication is provided bycontroller 220, which actuates PASS indicator 242 accordingly.

It is a particular feature of an embodiment of the present inventionthat at this stage, coupler 200 is preferably disengaged from thenormally-closed leak test port 106 of endoscope 100, which maintains theinterior volume of the endoscope under negative pressure and the balloon110 in a deflated state. This feature is not necessary with non-balloonendoscopes. Preferably, deflation of balloon 110 is performed bydepressurizing the interior volume of endoscope 100 to a negativepressure in the range of −5 mbar to −300 mbar. More preferably,deflation of balloon 110 is performed by depressurizing the interiorvolume of endoscope 100 to a negative pressure in the range of −100 mbarto −250 mbar. According to a most preferred embodiment of the presentinvention, the balloon 110 is deflated to a negative pressure below −150mbar.

It is a particular feature of the present invention that the negativepressure testing procedure described hereinabove is provided.

It is a further particular feature of the present invention that thenegative pressure which is maintained in the interior volume of theendoscope following the negative pressure leak testing proceduredescribed hereinabove is sufficiently low to maintain negative pressurein the interior volume of the endoscope during reprocessing at elevatedtemperatures, which cause a reduction in the vacuum level in theinterior volume of the endoscope being reprocessed.

Particularly, the interior volume of a balloon endoscope beingreprocessed at an elevated temperature of 60 degrees Celsius, shouldpreferably be maintained at a negative pressure lower than −150 mbarwhen at ambient temperature prior to reprocessing.

It is appreciated that alternatively the negative pressure testing maytake place prior to the positive pressure testing. It is alsoappreciated that a single pump may alternatively be used to provide bothpressurization and depressurization of the interior volume of theendoscope 100. It is further appreciated that leak tester 126 issuitable for leak testing of both non-balloon and balloon endoscopes.

Reference is now made to FIGS. 5A and 5B, which are together asimplified flow chart of the operation of the leak tester of FIG. 3 inaccordance with another embodiment of the present invention.

As seen in FIGS. 5A and 5B, an initial step is to sealingly couple leaktest port coupler 200 to the leak test port 106 of endoscope 100, suchthat the interior volume of the endoscope is in fluid communication withthe leak tester 119.

Thereafter, all of valves 208, 210 and 232 (FIG. 3) are opened in orderto couple the interior volume of the endoscope to ambient pressure viathe leak tester 126. Once the interior volume of the endoscope 100reaches ambient pressure, sensor 230 is calibrated accordingly.

Thereafter, negative pressure leak testing is initiated, typically byclosing valves 208 and 232 and operating negative pressure pump 204 todepressurize the interior volume 114 of endoscope 100 to a preferrednegative pressure of typically −200 mbar, as sensed by sensor 230, andthereby to deflate balloon 110 of endoscope 100. Optionally, if thepreferred pressure of typically −200 mbar is not realized within 10seconds of onset of depressurization, a negative pressure test failureindication is provided by controller 220, which actuates FAIL indicator244 accordingly.

If negative pressure test failure is not indicated at this optionalstage, valve 210 is closed and then the negative pressure in theinterior volume of the endoscope 100 is monitored again, after typically20 seconds. If the negative pressure after 20 seconds has increased toabove a preferred threshold of typically −150 mbar, a negative pressuretest failure indication is provided by controller 220, which actuatesFAIL indicator 244 accordingly.

If negative pressure test failure is not indicated at this stage, thepressure in the interior volume of the endoscope 100 is monitored again,after typically a further 20 seconds. If the pressure after this further20 seconds has increased by more than 2 mbar, a negative pressure testfailure indication is provided by controller 220, which actuates FAILindicator 244 accordingly.

If negative pressure test failure is not indicated at this stage, apositive and negative pressure test success indication is provided bycontroller 220, which actuates PASS indicator 242 accordingly.

It is a particular feature of an embodiment of the present inventionthat at this stage, coupler 200 is preferably disengaged from thenormally-closed leak test port 106 of endoscope 100, which maintains theinterior volume of the endoscope under negative pressure and the balloon110 in a deflated state. This feature is not necessary with non-balloonendoscopes. Preferably, deflation of balloon 110 is performed bydepressurizing the interior volume of endoscope 100 to a negativepressure in the range of −5 mbar to −300 mbar. More preferably,deflation of balloon 110 is performed by depressurizing the interiorvolume of endoscope 100 to a negative pressure in the range of −100 mbarto −250 mbar. According to a most preferred embodiment of the presentinvention, the balloon 110 is deflated to a negative pressure below −150mbar.

It is a particular feature of the present invention that the negativepressure testing procedure described hereinabove is provided.

It is a particular feature of the present invention that the negativepressure which is maintained in the interior volume of the endoscopefollowing the negative pressure leak testing procedure describedhereinabove is sufficiently low to maintain negative pressure in theinterior volume of the endoscope during reprocessing at elevatedtemperatures, which cause a reduction in the vacuum level in theinterior volume of the endoscope being reprocessed.

Particularly, the interior volume of a balloon endoscope beingreprocessed at an elevated temperature of 60 degrees Celsius, ispreferably maintained at a negative pressure lower than −150 mbar whenat ambient temperature prior to reprocessing.

It is further appreciated that leak tester 126 is suitable for leaktesting of both non-balloon and balloon endoscopes.

Reference is now made to FIG. 6, which is a simplified system blockdiagram illustration of an automated reprocessing system 300 constructedand operative in accordance with a preferred embodiment of the presentinvention.

As seen in FIG. 6, the automated reprocessing system preferably includesa reprocessing chamber 302 in which an endoscope 304 to be reprocessedis located during reprocessing. The endoscope can be a conventionalnon-balloon endoscope, such as an EC 3890i colonoscope, commerciallyavailable from Pentax Europe GmbH, of 104 Julius-Vosseler St., 22527Hamburg, Germany, or a balloon endoscope, such as a G-EYE™ 3890icolonoscope, commercially available from Smart Medical Systems, ofRaanana, Israel.

Reprocessing functionality 306, which may be entirely conventional andtypically comprises a fluids supply subsystem including endoscopecleaning functionality 308 and endoscope disinfection functionality 310,is operatively associated with the reprocessing chamber 302. Atemperature sensor 312 is preferably located within the reprocessingchamber 302 for measuring the temperature of cleaning and ordisinfecting fluids located therein at any or all times duringreprocessing.

In accordance with a preferred embodiment of the present invention aleak testing subsystem 314 is provided for communication with a leaktest port 316 of endoscope 304. It is a particular feature of thepresent invention that the leak testing subsystem 314 provides negativepressure leak testing functionality, which is important for balloonendoscopes and may also be used for non-balloon endoscopes.

It is a further particular feature of the present invention that theleak testing subsystem 314 provides balloon deflation controlfunctionality which is operative to maintain the interior volume of theballoon in a negative pressure state during at least part of operationof the automated balloon endoscope reprocessing functionality 306, andpreferably during all of the operation of the automated balloonendoscope reprocessing functionality 306.

A user interface 320 (denoted by UI in FIG. 6) is preferably providedwhich includes an operator engageable switch 322, enabling an operatorto select a reprocessing mode suitable for a balloon endoscope or areprocessing mode suitable for a non-balloon endoscope. The userinterface 320 preferably also includes an indicator 324 which alerts theoperator to a leak test failure as well as an indicator 326, whichinforms the operator that reprocessing of endoscope 304 has beensuccessfully completed.

The leak testing subsystem 314 preferably includes a leak test portcoupler 330, which is adapted to connect with leak test port 316 of aconventional non-balloon endoscope or a conventional balloon endoscope.

A positive gas pressure source, such as an air pressure pump 332 and anegative gas pressure source, such as a vacuum pump 334 are preferablyconnected to leak test port coupler 330 via a manifold 336 andautomatically controllable valves 338 and 340 and a flexible tube 342. Acomputerized controller 350 is operative to control the operation ofpumps 332 and 334 and/or valves 338 and 340 in order to apply atdifferent times, positive pressure and negative pressure to the leaktest port 316 of endoscope 304 via the leak test port coupler 330.Alternatively, a single pump providing at different times, positive andnegative pressure may be employed. An example of such a pump is model250 EC, commercially available from Schwarzer Precision GmbH+Co. KG ofAm Lichtbogen 7, 45141 Essen, Germany.

Preferably, computerized controller 350 also controls the operation ofother components and functionalities of automated reprocessing system300, such as the operation of the reprocessing functionality 306, and iscoordinating the relative timing of operation of the fluid supplysubsystem and the leak testing subsystem.

A computerized pressure sensor 360 is preferably coupled to leak testport coupler 330 and is also coupled to pumps 332 and 334 via a valve362 and is configured to sense changes in pressure over time at the leaktest port of the endoscope both at a time when the leak test port isunder positive pressure and at a time when the leak test port is undernegative pressure.

Preferably, valve 362 is an automatically controllable two-state valve,which can be positioned in either an “open” state in which it connectstube 342 and manifold 336 to the ambient via a purge tube 364, and a“closed” state in which it connects manifold 336 and tube 342 to eachother while disconnecting them from purge tube 364 and preventing aircommunication with the ambient.

In accordance with a preferred embodiment of the present invention, thecomputerized controller 350 cooperates with the computerized pressuresensor 360 to carry out a negative pressure leak test protocol, twoexamples of which are described hereinbelow with reference to FIGS.7A-7B and 8A-8C.

Reference is now made to FIGS. 7A and 7B, which are together asimplified flow chart of the operation of the reprocessing system ofFIG. 6 in accordance with one embodiment of the present invention.

As seen in FIGS. 7A and 7B, an initial step is to sealingly couple leaktest port coupler 330 to the leak test port 316 of endoscope 304, suchthat the interior volume of the endoscope is in fluid communication withthe leak testing subsystem 314.

Thereafter, the operator preferably uses switch 322 to select thesuitable reprocessing mode for the endoscope being reprocessed. If anon-balloon reprocessing mode is selected, automated reprocessing system300 perform a conventional, non-balloon endoscope reprocessingprocedure, such as performed in prior art automated reprocessingsystems.

In accordance with an embodiment of the present invention, endoscope 304being reprocessed is the balloon endoscope 100 described hereinabovewith reference to FIGS. 1A-2, which includes balloon 110, aperture 116that normally enables air flow between the interior volumes of balloon110 and endoscope 100, and mechanical shutter 122 which can be employedto seal aperture 116.

In accordance with this embodiment of the present invention, themechanical shutter 122 is employed, prior to reprocessing of balloonendoscope 100 by automated reprocessing system 300, to seal aperture 116as described hereinabove with reference to step B in FIG. 1C, and theoperator uses switch 322 to select a non-balloon endoscope reprocessingmode. Thus, automated reprocessing machine 300 is employed to performconventional reprocessing which may include positive pressure leaktesting of balloon endoscope 100, without bursting or damaging balloon110. It is appreciated that alternatively, sealing of aperture 116allows conventional reprocessing of balloon endoscope 100 by aconventional prior art automated reprocessing machine that employsrelatively high positive pressure while monitoring leaks during thereprocessing procedure, without bursting or damaging balloon 110.

In the description which follows, it is assumed, unless explicitlyindicated otherwise, that reprocessing of a balloon endoscope isselected, which balloon endoscope reprocessing is a particular featureof the present invention.

Thereafter, under the control of computerized controller 350, all ofvalves 338, 340 and 362 (FIG. 6) are opened in order to couple theinterior volume of the endoscope to ambient pressure via the leaktesting subsystem 314. Once the interior volume of endoscope 304 reachesambient pressure, pressure sensor 360 is calibrated accordingly.

Negative pressure leak testing is initiated, typically by closing valves338 and 362 and operating negative pressure pump 334 to depressurize theinterior volume of endoscope 304 to a preferred negative pressure oftypically −200 mbar, as sensed by pressure sensor 360, and thereby todeflate the balloon of endoscope 304. Optionally, if the preferredpressure of typically −200 mbar is not realized within 10 seconds ofonset of depressurization, a negative pressure test failure indicationis provided by controller 350, which actuates FAIL indicator 324accordingly and terminates reprocessing.

If negative pressure test failure is not indicated at this optionalstage, valve 340 is closed and then the negative pressure in theinterior volume of the endoscope 304 is monitored again, after typically20 seconds. If the negative pressure after 20 seconds has increased toabove a preferred threshold of typically −150 mbar, a negative pressuretest failure indication is provided by controller 350, which actuatesFAIL indicator 324 accordingly and terminates reprocessing.

If negative pressure test failure is not indicated at this stage, thepressure in the interior volume of the endoscope 304 is monitored again,after typically a further 20 seconds. If the pressure after this further20 seconds has increased by more than 2 mbar, a negative pressure testfailure indication is provided by controller 350, which actuates FAILindicator 324 and terminates reprocessing accordingly.

If negative pressure test failure is not indicated at this stage,preferably all of valves 338, 340 and 362 (FIG. 6) are opened and thepressure in the interior volume of the endoscope 304 is monitoredcontinuously by pressure sensor 360. Once the pressure in the interiorvolume of the endoscope 304, as measured by pressure sensor 360, rises,to typically −30 mbar, valves 338, 340 and 362 are closed in order tomaintain this negative pressure in the interior volume of endoscope 304.

Preferably, deflation of the balloon of balloon endoscope 304, duringand in between leak testing cycles, is performed and maintained bydepressurizing the interior volume of endoscope 304 to a negativepressure in the range of −5 mbar to −300 mbar. More preferably,deflation of the balloon of balloon endoscope 304, during and in betweenleak testing cycles, is performed and maintained by depressurizing theinterior volume of endoscope 304 to a negative pressure in the range of−100 mbar to −250 mbar. According to a preferred embodiment of thepresent invention, the balloon of balloon endoscope 304 is deflated to anegative pressure below −150 mbar.

It is a particular feature of an embodiment of the present inventionthat leak testing of a balloon endoscope takes place when the interiorvolume of the endoscope is at a relatively strong vacuum, typicallybetween −150 mbar and −200 mbar and the remainder of the reprocessingprocedure takes place when the interior volume of the endoscope is at arelatively weak vacuum, typically between −10 mbar and −50 mbar, andpreferably −30 mbar.

Preferably, the foregoing negative leak test procedure is repeated atgenerally regular intervals during reprocessing, such as every 2-5minutes.

Once reprocessing has been successfully completed in the absence of anynegative pressure leak test failures, a successful reprocessingindication is provided by controller 350, which actuates indicator 326accordingly.

It is a particular feature of an embodiment of the present inventionthat at this stage, coupler 330 is preferably disengaged from thenormally-closed leak test port 316 of endoscope 304, which maintains theinterior volume of the endoscope under negative pressure and the balloonof balloon endoscope 304 in a deflated state. It is appreciated thatstorage of balloon-endoscope 304 with a deflated balloon may bebeneficial for protecting the balloon from mishandling and puncture, aswell as for enabling placement of a protective cover over the balloon.This feature is not necessary with non-balloon endoscopes.

Reference is now made to FIGS. 8A-8C, which are together a simplifiedflow chart of the operation of the reprocessing system of FIG. 6 inaccordance with another embodiment of the present invention.

As seen in FIGS. 8A-8C, an initial step is to sealingly couple leak testport coupler 330 to the leak test port 316 of endoscope 304, such thatthe interior volume of the endoscope is in fluid communication with theleak testing subsystem 314.

Thereafter, the operator preferably uses switch 322 to select thesuitable reprocessing mode for the endoscope being reprocessed. If anon-balloon reprocessing mode is selected, automated reprocessing system300 perform a conventional, non-balloon endoscope reprocessingprocedure, such as performed in prior art automated reprocessingsystems. In the description which follows, it is assumed, unlessexplicitly indicated otherwise, that reprocessing of a balloon endoscopeis selected, which balloon endoscope reprocessing is a particularfeature of the present invention.

Thereafter, under the control of computerized controller 350, all ofvalves 338, 340 and 362 (FIG. 6) are opened in order to couple theinterior volume of the endoscope to ambient pressure via the leaktesting subsystem 314. Once the interior volume of the endoscope 304reaches ambient pressure, pressure sensor 360 is calibrated accordingly.

Negative pressure leak testing is initiated, typically by closing valves338 and 362 and operating negative pressure pump 334 to depressurize theinterior volume of endoscope 304 to a preferred negative pressure oftypically −200 mbar, as sensed by pressure sensor 360, and thereby todeflate the balloon of endoscope 304. Optionally, if the preferredpressure of typically −200 mbar is not realized within 10 seconds ofonset of depressurization, a negative pressure test failure indicationis provided by controller 350, which actuates FAIL indicator 324accordingly and terminates reprocessing.

If negative pressure test failure is not indicated at this optionalstage, valve 340 is closed and then, after typically 20 seconds, at atime designated t0, the negative pressure in the interior volume of theendoscope 304 is again monitored by pressure sensor 360 and thetemperature within the reprocessing chamber 302 is measured bytemperature sensor 312. The measured negative pressure at this stage, attime t0, is designated P0 and the measured temperature at t0 isdesignated T0.

If the negative pressure P0 is higher than a preferred threshold oftypically −150 mbar, a negative pressure test failure indication isprovided by controller 350, which actuates FAIL indicator 324accordingly and terminates reprocessing.

If negative pressure test failure is not indicated at this stage, thepressure in the interior volume of the endoscope 304 and the temperaturewithin the reprocessing chamber 302 are monitored again at time t, aftera time interval from t0 denoted by Dt, which is dictated by computerizedcontroller 350. If periodical intermittent leak monitoring is required,time interval Dt may be a predetermined time interval such as agenerally short time interval in the range of 1-60 seconds or agenerally longer time interval in the range of 1-5 minutes.Alternatively, if continuous leak monitoring is desired such that leaksensing cycles are performed immediately one after the other, timeinterval Dt may be the electronic clock time unit of computerizedcontroller 350 or a multiplicity thereof.

It is appreciated that even in the absence of a leak, the vacuum withinthe interior volume of the endoscope 304 is weakened as a function oftemperature increase. It is further appreciated that the vacuum withinthe interior volume of the endoscope 304 may be weakened very slowly asa function of elapsed time due to imperfections in sealing betweenvarious components which are maintained under vacuum and this weakeningis not indicative of an unacceptable leak in the balloon endoscope,which should be identified as a leak test failure.

Accordingly, controller 350 sets an acceptable negative pressurethreshold PT(t) which varies as a function of temperature as measured bytemperature sensor 312 and as a function of elapsed time from time t0.Should the pressure P(t) measured by sensor 360 at any given time texceed the corresponding acceptable negative pressure threshold PT(t), afailure will be indicated.

The negative pressure threshold PT(t) at a time t, measured at a giventime after time t0, is preferably given by the following generalexpression:

PT(t)=F(Tt,T0,t,t0,P0),

F being a function of Tt, T0, t, t0 and P0, where:

Tt is the temperature of the interior of the reprocessing chamber 302 attime t, as measured by temperature sensor 312;

T0 is the temperature of the interior of the reprocessing chamber 302 attime t0, as measured by temperature sensor 312; and

P0 is the negative pressure in the interior volume of the endoscope 304at time t0, as measured by pressure sensor 360.

In accordance with a preferred embodiment of the present invention,F(Tt, T0, t, t0, P0) is embodied in a predetermined calibration table,which is stored in computerized controller 350. Controller 350 retrievesthe appropriate negative pressure threshold PT(t) for each set ofspecific values of Tt, T0, t, t0 and P0.

It is appreciated that if the temperature profile in the reprocessingchamber throughout the reprocessing procedure, as measured bytemperature sensor 312, is known a priori, such as by employing apredetermined heating profile for the solutions employed throughout thereprocessing procedure, then PT(t) can be calculated or retrieved as afunction of P0 and t, and actual measurement of the temperature T(t) bytemperature sensor 312 may be obviated.

More particularly in accordance with a preferred embodiment of thepresent invention, negative pressure threshold PT(t) at a given time tis expressed by the following function:

PT(t)=F1(Tt,T0,P0)+F2(t−t0)

where:

F1 is a function of the relationship between Tt, the temperaturemeasured by temperature sensor 312 at a given time t, and T0 and P0, therespective temperature measured by temperature sensor 312 and pressuremeasured by pressure sensor 360 at time t0; and

F2 is a function of the elapsed time from time t0 to t.

Preferably, F1 is given by the expression: F1=(Tt/T0)·P0, where Tt andT0 are measured in degrees Kelvin and P0 is measured in the absolutepressure units above zero pressure, such as mbar or atmospheres, as usedfor PT(t).

Preferably, F2 is given by the expression: F2=K·(t−t0), where K is aconstant, expressing change in pressure over time. In accordance with apreferred embodiment of the present invention, K is in the range of0.01-0.20 mbar per second. In accordance with a more preferredembodiment of the present invention, K is in the range of 0.02-0.10 mbarper second. In accordance with a presently most preferred embodiment ofthe present invention, K is approximately 0.05 mbar per second.

The pressure P(t) and the temperature T(t) at time t are measured byrespective pressure sensor 360 and temperature sensor 312 continuouslyor intermittently as appropriate. Should the measured negative pressureP(t) be higher than the negative pressure threshold PT(t) a negativepressure test failure indication is provided by controller 350, whichactuates FAIL indicator 324 accordingly and terminates reprocessing.

Once reprocessing has been successfully completed in the absence of anynegative pressure leak test failures, a successful reprocessingindication is provided by controller 350, which actuates indicator 326accordingly.

It is a particular feature of an embodiment of the present inventionthat at this stage, coupler 330 is preferably disengaged from thenormally-closed leak test port 316 of endoscope 304, which maintains theinterior volume of the endoscope under negative pressure and the balloonof balloon endoscope 304 in a deflated state. It is appreciated thatstorage of balloon-endoscope 304 with a deflated balloon may bebeneficial for protecting the balloon from mishandling and puncture, aswell as for enabling placement of a protective cover over the balloon.This feature is not necessary with non-balloon endoscopes.

Reference is now made to FIGS. 9A and 9B, which are simplifiedillustrations of a reprocessing method operative in accordance withanother preferred embodiment of the present invention.

As seen in 9A and 9B, there is provided a reprocessing method for aballoon endoscope, which is particularly characterized in that itincludes:

inflating a balloon of a balloon endoscope to a positive pressure statefollowing clinical use thereof;

thereafter, cleaning and/or disinfecting the outer surface of theballoon while the balloon is inflated in a positive pressure state;

thereafter, deflating the balloon of the balloon endoscope to a negativepressure state; and thereafter

maintaining the interior of the balloon in a negative pressure stateduring at least part of reprocessing said balloon endoscope.

There is also provided a method for reprocessing a balloon endoscopehaving a balloon interior volume and an endoscope interior volume whichare normally in fluid communication via at least one aperture, themethod comprising sealing the at least one aperture during at least partof reprocessing of the balloon endoscope.

FIGS. 9A and 9B illustrate steps carried out in an endoscopy room. StepA, shown in FIG. 9A, illustrates a balloon endoscope 400, such as amodel G-EYE™ 3890i colonoscope, commercially available from SmartMedical Systems of Raanana, Israel, after having been removed from thebody of a patient following an endoscopic procedure, such as acolonoscopy. At this stage, the balloon of the balloon endoscope 400 maybe inflated or deflated.

During the endoscopic procedure and immediately thereafter at Steps A, Band C, the balloon endoscope 400 is operatively connected with aninflation/deflation system 402, such as a SPARK2C inflation system,commercially available from Smart Medical Systems of Raanana, Israel.Specifically a flexible inflation/deflation tube 404 is sealinglyconnected at one end thereof to a normally-closed leak-test port 406 ofballoon endoscope 400, as seen in enlargement B, and is sealinglyconnected at an opposite end thereof to an inflation/deflation tubeconnection port 408 of the inflation/deflation system 402.

As further seen in FIGS. 9A and 9B, balloon endoscope 400 includes aballoon 410 at its forward portion, which is sealingly mounted over anouter sheath 412 of balloon endoscope 400. An interior volume 413 ofballoon 410 is normally in fluid communication with an interior volume414 of balloon endoscope 400, via at least one aperture 416 formed inthe outer sheath 412 of the endoscope 400. It is thus appreciated thatballoon 410 may be inflated and deflated by inflation/deflation system402 via flexible inflation/deflation tube 404, leak test port 406,interior volume 414 of balloon endoscope 400, and at least one aperture416, altogether forming a continuous fluid communication path betweeninflation/deflation system 402 and the interior volume 413 of balloon410.

It is appreciated that the volume of balloon endoscope 400 interiorly ofouter sheath 412 may contain various conduits and channels (not shown)passing therethrough, such as optical and illumination bundles,electronics, steering wires, an instrument channel, and other componentsas appropriate. It is appreciated that inflation/deflation air can flowfreely through the interior volume 414, which is the volume interior toouter sheath 412 that is not occupied by such conduits and channels.

In step B, shown in FIG. 9A, it is seen that if the balloon 410 of theendoscope 400 is not already fully inflated, the operator presses on aninflate control button 417 of an inflation/deflation control unit 418 ofthe inflation/deflation system 402 to cause the inflation/deflationsystem 402 to fully inflate the balloon 410. At this stage, the inflatedballoon 410 is cleaned and/or disinfected, such as by immersing balloon410 in cleaning and/or disinfecting solutions and wiping it with a softsponge or cloth, as shown in enlargement A, or by any other suitablecleaning and/or disinfecting procedure.

In step C, shown in FIG. 9A, it is seen that following the cleaningand/or disinfecting of balloon 410 while it is in an inflated state, theoperator presses on a deflate control button 419 of theinflation/deflation control unit 418 of the inflation/deflation system402 to cause the inflation/deflation system 402 to fully deflate theballoon 410, as seen in enlargement C.

It is a particular feature of an embodiment of the present inventionthat deflation of the balloon 410 effects sealing, as shown inenlargement D, during at least part of reprocessing of the balloonendoscope, of the at least one aperture 416 formed in the outer sheath412 of the endoscope 400, which aperture normally provides fluidcommunication between the interior volume 413 of balloon 410 and theinterior volume 414 of the endoscope 400. This is important in order toensure that any reprocessing fluids that might somehow enter theinterior volume 413 of balloon 410 from the outside during reprocessingdo not enter the interior volume 414 of the endoscope.

It is appreciated that such sealing, during at least part ofreprocessing of the balloon endoscope, of the at least one aperture 416,could be provided otherwise than by means of deflation of the balloon410, such as by a mechanical sealing element or shutter that blocks theat least one aperture 416 and prevents flow of fluids therethrough, asdescribed hereinabove with reference to FIGS. 1B and 1C.

Referring now to FIG. 9B, at step D the operator disconnects theflexible inflation/deflation tube 404 from normally-closed leak-testport 406 of balloon endoscope 400. Due to the normally-closed operationof leak-test port 406, interior volume 414 of endoscope 400 remains in avacuum state and the balloon 410 remains fully deflated.

Step E of FIG. 9B, shows subsequent shut-down of the inflation/deflationsystem 402.

It is a particular feature of the embodiment of the present inventiondescribed with reference to FIGS. 9A and 9B that balloon endoscope 400,while balloon 410 is in a deflated state, is disconnected frominflation/deflation system 402 while the inflation/deflation system 402is powered on and thereby maintaining vacuum in interior volume 414 ofendoscope 400 and deflation of balloon 410, and that system 402 ispowered off only after its disconnection from endoscope 400.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather the scope of the invention includes bothcombinations and subcombinations of the various features describedhereinabove as well as modifications and variations thereof which wouldoccur to persons skilled in the art upon reading the foregoingdescription and which are not in the prior art.

1. A leak testing device for use with an endoscope having a leak testport, said leak testing device comprising: negative pressure leak testfunctionality configured to be coupled to a leak test port of anendoscope for sensing leaks in said endoscope under negative pressure;and an indicator operative in response to operation of said negativepressure leak test functionality for indicating the presence or absenceof a leak in said endoscope.
 2. A leak testing device for use with anendoscope according to claim 1 and wherein said negative pressure leaktest functionality is operative for performing said leak testing whensaid negative pressure is in the range of −5 mbar to −300 mbar.
 3. Aleak testing device for use with an endoscope according to claim 1 andwherein said negative pressure leak test functionality is operative forperforming said leak testing when said negative pressure is in the rangeof −100 mbar to −250 mbar.
 4. A leak testing device for use with anendoscope according to claim 1 and wherein said negative pressure leaktest functionality is operative for performing said leak testing whensaid negative pressure is below −150 mbar.
 5. A leak testing device foruse with an endoscope according to claim 1 which is suitable for use inconjunction with reprocessing of a balloon endoscope having an interiorvolume and wherein said device also comprises negative pressureestablishment functionality operative subsequent to at least one leaktest to establish a negative pressure in said interior volume of saidballoon endoscope which is suitable for reprocessing of said balloonendoscope.
 6. A leak testing device for use with an endoscope accordingto claim 1 and also comprising positive pressure leak testingfunctionality.
 7. A leak testing device for use with an endoscopeaccording to claim 6 and wherein said positive pressure leak testingfunctionality includes functionality for eliminating false leakindications resulting from expansion of an endoscope balloon over timeduring leak testing.
 8. A leak testing device for use with an endoscopeaccording to claim 1 and also comprising automatic balloonendoscope/non-balloon endoscope sensing functionality.
 9. A leak testingdevice for use with an endoscope according to claim 8 and alsocomprising a computerized controller for operating said leak testingdevice differently depending on whether it is connected to a balloonendoscope or a non-balloon endoscope.
 10. A leak testing method for usewith an endoscope having a leak test port, the method comprising:coupling negative pressure leak test functionality to an interior volumeof an endoscope; employing said negative pressure leak testfunctionality for sensing leaks in said endoscope under negativepressure; and in response to operation of said negative pressure leaktest functionality, indicating the presence or absence of a leak in saidendoscope.
 11. A leak testing method for use with an endoscope accordingto claim 10 and wherein said negative pressure leak test functionalityis operative for performing said leak testing when said negativepressure is in the range of −5 mbar to −300 mbar.
 12. A leak testingmethod for use with an endoscope according to claim 10 and wherein saidnegative pressure leak test functionality is operative for performingsaid leak testing when said negative pressure is in the range of −100mbar to −250 mbar.
 13. A leak testing method for use with an endoscopeaccording to claim 10 and wherein said negative pressure leak testfunctionality is operative for performing said leak testing when saidnegative pressure is below −150 mbar.
 14. A leak testing method for usewith an endoscope according to claim 10 which is suitable for use inconjunction with reprocessing of a balloon endoscope having an interiorvolume and wherein said method also comprises, subsequent to performingat least one leak test, establishing a negative pressure in saidinterior volume of said balloon endoscope which negative pressure issuitable for reprocessing of said balloon endoscope.
 15. A leak testingmethod for use with an endoscope according to claim 10 and alsocomprising positive pressure leak testing.
 16. A leak testing method foruse with an endoscope according to claim 15 and wherein said positivepressure leak testing includes eliminating false leak indicationsresulting from expansion of an endoscope balloon over time during leaktesting.
 17. A leak testing method for use with an endoscope accordingto claim 10 and also comprising automatic sensing of a connection toeither a balloon endoscope or a non-balloon endoscope.
 18. A leaktesting method for use with an endoscope according to claim 17 and alsocomprising operating said leak testing device differently depending onwhether it is connected to a balloon endoscope or a non-balloonendoscope.